Severe post-partum haemorrhage Pregnancy and Childbirth Postpartum haemorrhage
Conditions
Interventions
A collector bag, placed under the pelvis (buttocks) of each woman just after birth.
Sponsors
European Union DG Research
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Maternity units in 14 countries; To ensure that the standard of care for management of the third stage of labour is similar across all participating units, the maternity units in each country will be required to comply with the EUPHRATES consensus statement on the prevention and management of post-partum haemorrhage. If centres are already using collector sacs routinely in the third stage of labour, they will be eligible to participate only if they are willing to stop using the sacs if they are randomised to that group.
Exclusion criteria
Exclusion criteria: Maternity units with less than 400 births per year or unable to collect outcome data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is a composite marker of severe post-partum haemorrhage. This includes all women who experience one or more of the following: 1. Death from post-partum haemorrhage 2. Blood transfusion 3. Receipt of an intravenous plasma expander in the post-partum period 4. Admission to intensive care because of post-partum haemorrhage 5. Embolisation or surgical procedures for post-partum haemorrhage, such as emergency hysterectomy 6. Treatment with recombinant factor VII (Novo7) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Each of the components of the primary outcome 2. Post-delivery haemoglobin (Note: these data will only be available from units where haemoglobin is routinely measured at two to three days after delivery) 3. Manual removal of placenta 4. Use of prostaglandins 5. Maternal death | — |
Countries
Belgium
Outcome results
None listed